氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.677077770683705847092670662707260.19
210.757074970628706880.13
单位质量响应值RSD%判断
6628.496575.630.57数据可信
供试品溶液-2024041521批-pH1.0盐酸溶液-无水乙醇(95:5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.18244.950.000.18244.95
2-0.0000.00
3-0.0000.00
47891-78911.1041.10
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00244.95
2-0.0000.00
3-0.0000.00
4-0.0000.01
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00244.95
2-0.0000.00
3-0.0000.00
4-0.0000.01
5-0.0000.00
6-0.0000.00
60min19123-91231.2760.24211.031.280.24208.99
21269-12690.1780.18
3-0.0000.00
4-0.0000.01
5-0.0000.00
6-0.0000.00
75min11319-13190.1850.41175.830.200.42174.88
21447-14470.2020.20
31495-14950.2090.21
413445-134451.8811.89
5-0.0000.00
6-0.0000.00
90min12624-26240.3670.3015.090.380.3113.79
22050-20500.2870.29
32125-21250.2970.30
41715-17150.2400.27
51943-19430.2720.27
62388-23880.3340.33
120min13135-31350.4390.3810.860.460.3912.88
22457-24570.3440.35
32456-24560.3440.35
42845-28450.3980.43
52897-28970.4050.41
62441-24410.3420.34
极限16591-65910.9221.0228.060.941.0327.29
25855-58550.8190.83
36559-65590.9180.93
46718-67180.9400.98
511394-113941.5941.60
66529-65290.9130.92
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.677072771732708207052170781709160.67
210.757057770541705590.04
单位质量响应值RSD%判断
6646.306563.630.89数据可信
供试品溶液-2024041721批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.03244.950.000.03244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
51334-13340.1870.19
6-0.0000.00
30min1-0.0000.12244.950.000.12244.95
24938-49380.6910.69
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.18244.950.000.18242.29
2-0.0000.01
3-0.0000.00
47827-78271.0951.09
5-0.0000.00
6-0.0000.00
60min11501-15010.2100.2823.410.210.2822.82
22397-23970.3350.34
32132-21320.2980.30
41308-13080.1830.19
52375-23750.3320.33
62201-22010.3080.31
75min1-0.0000.28107.540.000.28106.10
21719-17190.2400.25
35690-56900.7960.80
41505-15050.2100.22
53102-31020.4340.44
6-0.0000.00
90min11802-18020.2520.3630.550.250.3730.88
22940-29400.4110.42
32028-20280.2840.29
42660-26600.3720.39
53932-39320.5500.56
62103-21030.2940.30
120min12597-25970.3630.5135.300.370.5335.09
25038-50380.7050.72
32865-28650.4010.41
42735-27350.3820.40
55591-55910.7820.80
63244-32440.4540.46
极限16224-62240.8700.899.710.880.909.36
26833-68330.9560.98
36287-62870.8790.90
45199-51990.7270.75
56802-68020.9510.97
66676-66760.9340.94
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.677070070251706667003270264703830.42
210.756981569446696300.38
单位质量响应值RSD%判断
6596.346477.211.29数据可信
供试品溶液-2024041521批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.02244.950.000.02244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6687-6870.0970.10
60min1855-8550.1210.1363.670.120.1363.39
2910-9100.1290.13
3611-6110.0860.09
41540-15400.2180.22
5-0.0000.00
61471-14710.2080.21
75min1-0.0000.1461.530.000.1461.81
2869-8690.1230.12
3680-6800.0960.10
41612-16120.2280.23
51328-13280.1880.19
61579-15790.2230.23
90min11940-19400.2740.2518.290.280.2619.50
21543-15430.2180.22
31554-15540.2200.22
41711-17110.2420.25
51648-16480.2330.23
62406-24060.3400.35
120min13305-33050.4670.3924.990.470.3924.85
22583-25830.3650.37
32794-27940.3950.40
43172-31720.4480.46
51449-14490.2050.21
63122-31220.4410.45
极限16901-69010.9750.8711.130.980.8810.89
27062-70620.9981.01
35514-55140.7790.79
45902-59020.8340.85
55536-55360.7820.79
65862-58620.8280.84
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.676979769580700366954970132698190.38
210.757004069566698030.49
单位质量响应值RSD%判断
6543.496493.300.55数据可信
供试品溶液-2024041721批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.04157.790.000.04158.12
2-0.0000.00
3-0.0000.00
4732-7320.1040.10
5-0.0000.00
61008-10080.1430.14
60min11357-13570.1920.2027.400.190.2027.79
21305-13050.1850.18
31977-19770.2800.28
41123-11230.1590.16
5917-9170.1300.13
61670-16700.2370.24
75min1761-7610.1080.1456.160.110.1456.61
21193-11930.1690.17
3-0.0000.00
41371-13710.1940.20
5979-9790.1390.14
61503-15030.2130.22
90min11551-15510.2200.2642.220.220.2641.86
2770-7700.1090.11
31972-19720.2790.28
41891-18910.2680.27
53180-31800.4510.45
61751-17510.2480.25
120min14316-43160.6120.3933.000.620.4031.82
22337-23370.3310.34
32415-24150.3420.35
43148-31480.4460.45
51752-17520.2480.26
62380-23800.3370.35
极限15344-53440.7570.7118.400.770.7217.81
26749-67490.9560.96
34913-49130.6960.71
44438-44380.6290.64
54303-43030.6100.62
64439-44390.6290.64
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.678670886267863678686287196866800.44
210.756978169623697020.17
单位质量响应值RSD%判断
8123.716483.9115.88数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024041821批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.09244.950.000.09244.95
2-0.0000.00
34327-43270.5540.55
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00244.95
2-0.0000.00
3-0.0000.01
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00244.95
2-0.0000.00
3-0.0000.01
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.04154.980.000.04145.78
2-0.0000.00
3-0.0000.01
4-0.0000.00
5923-9230.1180.12
6880-8800.1130.11
75min1-0.0000.04158.270.000.04150.74
2-0.0000.00
3-0.0000.01
4-0.0000.00
5797-7970.1020.10
61126-11260.1440.15
90min1-0.0000.09118.650.000.09118.01
2-0.0000.00
3964-9640.1230.13
41250-12500.1600.16
5-0.0000.00
61930-19300.2470.25
120min1-0.0000.1883.000.000.1883.08
2-0.0000.00
32183-21830.2800.29
42075-20750.2660.27
51399-13990.1790.18
62699-26990.3460.35
极限11174-11740.1500.5852.030.150.5852.44
21982-19820.2540.25
36202-62020.7940.80
45208-52080.6670.67
55594-55940.7160.72
66808-68080.8720.88
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.676951369115689606938669384692720.33
210.756981369504696580.32
单位质量响应值RSD%判断
6492.226479.810.14数据可信
供试品溶液-2024041821批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1-0.0000.27244.950.000.27244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
511527-115271.6421.64
6-0.0000.00
30min1-0.0000.00-0.000.00244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.02
6-0.0000.00
45min1-0.0000.00-0.000.00244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.02
6-0.0000.00
60min1-0.0000.00-0.000.00244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.02
6-0.0000.00
75min12332-23320.3320.12103.050.330.1298.32
2-0.0000.00
3797-7970.1140.11
41084-10840.1540.15
5-0.0000.02
6792-7920.1130.11
90min11314-13140.1870.1627.180.190.1626.74
2663-6630.0940.09
31301-13010.1850.19
41227-12270.1750.18
5801-8010.1140.13
61371-13710.1950.20
120min12746-27460.3910.2725.550.400.2824.95
21702-17020.2420.24
32265-22650.3230.33
41771-17710.2520.26
51616-16160.2300.25
61433-14330.2040.21
极限16106-61060.8700.7710.330.880.7810.10
24669-46690.6650.67
35465-54650.7780.78
45601-56010.7980.80
54852-48520.6910.71
65835-58350.8310.84
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